EP0887062A1

EP0887062A1 - Faecal collector

Info

Publication number: EP0887062A1
Application number: EP97110603A
Authority: EP
Inventors: Gianfranco Palumbo; Vincenzo D'acchioli
Original assignee: Procter and Gamble Co
Current assignee: Procter and Gamble Co
Priority date: 1997-06-28
Filing date: 1997-06-28
Publication date: 1998-12-30

Abstract

The present invention relates to a shaped faecal management device. The faecal management device comprises a bag having an aperture, and an anatomically-shaped flange, which surrounds the aperture. The flange provides for adhesive attachment to the perianal area of the wearer. In particular, the bag comprises at least two distinct portions: a wearer facing portion and a garment facing portion wherein the wearer facing portion and the garment facing portion are secured at the periphery of the bag. The wearer facing portion has a surface area that is greater than that of the garment facing portion. In another aspect of the present invention, the faecal management device is used in combination with a disposable diaper.

Description

Field of the invention

The present invention relates to a faecal management device that is so shaped as to fit closely to the buttocks of the wearer for superior functionality and comfort.

Background of the invention

Faecal management devices are known articles of manufacture that are designed to be worn principally by incontinence sufferers and infants. Such faecal management devices are attached to the anal region of the wearer and are intended to entrap and immediately contain faecal material and other bodily discharges. As a consequence, these devices are functionally effective in eliminating the problem of smearing on the skin of the wearer; in lessening epidermal irritation; in preventing contamination of articles such as clothing and bedding; and even in preventing the soiling of the carers themselves.

Nevertheless, a problem often encountered is that the current devices on the market are so shaped and dimensioned as to frequently lead to twisting around the thighs of the wearers and to folds and kinks in the devices themselves. Such features naturally affect the storage capacity of the device and may result in unintentional detachment of the device from the wearer leading to undesirable and distressing consequences both for the wearer and carer. Furthermore, the positioning of the device in the thigh regions due to its dimensions may cause discomfort to the bedridden wearer or to the infant, resulting not only from possible twisting of the device, but also from the rubbing of the device against the skin of the wearer, which leads to occlusion and creates hot clammy conditions and stickiness, reddening, skin rashes and perhaps, even lead to a more severe skin irritation and ultimately to the disgarding of the device.

Typical of the prior art faecal management devices are US 3,577,989, which details a disposable elimination-trapping bag for incontinence sufferers including a container member having an open-top portion, and a flange secured to the container member around the open-top portion. The container member includes two opposed side members, preferably substantially identical, and of a generally rectangular configuration, joined together along common edges. US 4,784,656 describes a receptacle for collecting faecal matter from incontinence sufferers. The faecal collector comprises a gasket, conduit means or a cylinder and a receptacle. The receptacle and conduit means are each formed from two sheets of odour barrier thermoplastic film that are heat sealed along their side edges, respectively. GB 2 152 387 describes a faecal collector for incontinence sufferers comprising a collection bag and a ring. The faecal collector comprises a pair of panels of thermoplastic sheet material joined at their margins to define an elongate bag having an opening at one end. In a preferred embodiment, the collection bag is formed from a single sheet of odour-barrier thermoplastic film folded along a vertical midline to provide a pair of continuous panels. SE 8 104 934 describes an oblong bag made from a thin, flexible and fluid tight material. The collecting bag comprises an inlet portion and a bottom portion at an angle of 120 degrees to the longitudinal direction of the inlet portion. The bag is so designed as to enable it to assume an advantageous position along the thigh of the person when in use. As is evident, the prior art reveals devices that are cumbersome, that are capable of twisting and that can cause skin problems due to continuous rubbing because of dimensions of the devices.

Therefore, a real consumer need can be identified for a faecal management device, which is correctly shaped and dimensioned so as to guarantee the wearer maximum functionality, excellent coverage of the buttocks, and superior comfort. The present invention addresses this need by designing a faecal management device with a specific shape and dimension. It has been found that the resultant faecal management device is uniquely advantageous and exhibits an enhanced level of efficiency and comfort. In another aspect of the present invention, the faecal management device with its specifically designed shape and dimensions can be advantageously used with a disposable diaper. In this manner, the design of the faecal management device can be capitalised upon to reduce not only the problem of occlusion, epidermal irritations, and lack of storage capacity caused by folds and kinks, but also contribute greatly to improved skin healthiness and lead to very satisfied wearers.

Summary of the invention

A faecal management device constructed in accordance with the present invention comprises a bag having an aperture and an anatomically shaped flange surrounding the aperture for adhesive attachment to the perianal area of the wearer. The anatomically-shaped flange is attached to the bag. The bag comprises two distinct portions: a wearer facing portion and a garment facing portion, which are secured at the periphery of the bag. The wearer facing portion has a surface area greater than that of the garment facing portion. In a preferred embodiment of the present invention, the bag has a substantially truncated cone shape. In another preferred embodiment of the present invention, the wearer facing portion and garment facing portion are endowed with a non-woven layer.

In another aspect of the present invention, the present faecal management device is used in combination with a disposable diaper.

Brief description of the drawings

It is believed that the invention will be better understood from the foregoing description in conjunction with the accompanying drawings in which:

Figure 1 is a shaped faecal management device in accordance with the teachings of the present invention;

Figure 2 is a side view of a faecal management device in accordance with Figure 1;

Figure 3 shows a perspective view of the faecal management device in conjunction with a disposable diaper; and

Figure 4 is a partially cut-away perspective view of a disposable diaper embodying the present invention.

Detailed description of the invention

As used herein, the term "layer" does not necessarily limit the bag to a single stratum of material. The term "non-woven" can refer to continuous filaments, or fibre webs and batts that are strengthened by bonding using various techniques. Furthermore, the term "non-woven" can encompass loose and unadhered fibres that are applied to another web or film.

According to Figure 1, the faecal management device 10 of the present invention comprises a bag 11 having an aperture and an anatomically-shaped flange 12 surrounding the aperture for adhesive attachment to the perianal area of the wearer. The anatomically-shaped flange 12 is attached to the bag 11 according to means known to the man skilled in the art. Preferably, the anatomically-shaped flange 12, which is substantially heart-shaped, is designed to closely follow the bodily contours of the wearer when in use. Furthermore, the flange 12 can be adapted to fit either a male or a female wearer. For a female wearer, the flange 12 at its front end portion comprises a projection that fits comfortably and snugly between the vulva and the anus, i.e., the perineum. For a male wearer, this projection is typically not present. The flange 12 comprises a body-compatible adhesive that is covered with a release means (not shown) in order to protect the adhesive layer. The adhesive can cover the entire surface of the flange 12 or can partially cover the entire surface. As is evident from Figure 1, the adhesive is not applied to the whole surface area of the flange 12. Lobes 13 on either side of the flange 12 remain free of adhesive to facilitate more easily the removal of the release means. Before application of the faecal management device 10 to the perianal area of the wearer, the release means is removed.

As is evident from Figures 1 and 2, the bag 11 comprises two distinct portions: a wearer facing portion 16 and a garment facing portion 17 wherein the wearer facing portion 16 has a surface area greater than the garment facing portion 17. In particular, the surface area of the wearer facing portion 16 is at least 1.3 times greater than the surface area of the garment facing portion 17 although this is not a limiting figure. The wearer facing portion 16 and the garment facing portion 17 are secured at the periphery 18 of the bag 11. In a preferred embodiment of the present invention, the bag 11 has a substantially truncated cone shape. The wearer facing portion 16 of the faecal management device 10 is disposed adjacent the buttocks of the wearer. As such, the wearer facing portion 16 amply covers the buttocks of the wearer and does not hang between the thighs of the wearer.

In yet another preferred embodiment of the present invention, the wearer facing portion 16 comprises more than one section 19. As is visible from Figure 1, the bag 11 comprises two sections 19, which are secured to each other according to means known to the man skilled in the art.

The wearer facing portion 16 and the garment facing portion 17 are provided with a non-woven layer. The non-woven layer can comprise felt fabrics, needlepunched fabrics, spunlaced fabrics, fluid jet entangled fabrics, air-laid fabrics, wet-laid fabrics, dry-laid fabrics, melt-blown fabrics, staple fibre carding fabrics, spunbonded fabrics, stitch-bonded fabrics, apertured fabrics, combinations of the above or the like. Such material layers present an uneven surface to the skin of the wearer and thus reduce significantly the problem of occlusion and greatly improve skin healthiness. The inner surface 15 of the wearer facing portion 16 and the garment facing portion 17 comprises a plastic film. The plastic film is preferably permeable to gases such as air and to vapour such as water vapour in order to avoid the problem of entrapment and condensation of moisture vapour given off by the body of the wearer and thus, the hot, clammy and uncomfortable conditions after a short period of use. In a preferred embodiment of the present invention, the non-woven layer and the plastic film are in the form of a laminate. The laminate can be formed by means known to the man skilled in the art.

In another preferred embodiment of the present invention, the inner surface 15 of the wearer facing portion 16 and the garment facing portion 17 comprises a thermoplastic material. The thermoplastic material can be selected from among all types of hot-melt adhesives, polyolefins especially polyethylene, polypropylene, amorphous polyolefins, and the like; materials containing meltable components comprising fibres or polymeric binders including natural fibres such as cellulose - wood pulp, cotton, jute, hemp; synthetic fibres such as fibreglass, rayon, polyester, polyolefin, acrylic, polyamid, aramid, polytetrafluroethylene metal, polyimide; binders such as bicomponent high melt/low melt polymer, copolymer polyester, polyvinyl chloride, polyvinyl acetate/chloride copolymer, copolymer polyamide, materials comprising blends wherein some of the constituent materials are not meltable; air and vapour permeable materials including microporous films such as those supplied by EXXON Chemical Co., III, US under the designation EXXAIRE or those supplied by Mitsui Toatsu Co., Japan under the designation ESPOIR NO; and monolithic breathable materials such as Hytrel® available from DuPont and Pebax® available from ELF Atochem, France.

In yet another preferred embodiment of the present invention, the inner surface 15 of the wearer facing portion 16 and the garment facing portion 17 comprises a second non-woven layer. The combination of the woven layer on the wearer facing portion 16 and the garment facing portion 17 and the second non-woven layer of the inner surface 15 results in a closed fibrous structure, which has a particularly pleasing sensation on contact with the skin of the wearer. In yet even a further embodiment of the present invention, the inner surface 15 comprises the second non-woven layer and a plastic film. The second non-woven layer of the inner surface 15 can lie either adjacent to the non-woven layer of the wearer facing portion 16 and the garment facing portion 17 with the plastic film lying furthest away from the non-woven layer or the second non-woven layer of the inner surface 15 can lie furthest away from the non-woven layer of the wearer facing portion 16 and the garment facing portion 17 with the plastic film being interposed therebetween.

For all embodiments of the present invention, the non-woven layer is preferably hydrophobic. As a consequence, fluid penetration is resisted through the wearer facing portion 16 and the garment facing portion 17 of the faecal management device 10. For the case of the inner surface 15 comprising a plastic film, the second non-woven layer can either be hydrophobic or hydrophilic and for the case of the inner surface 15 not comprising a plastic film, the second non-woven layer can be hydrophobic. Typically, the non-woven layer is treated with a surface active material, such as a fluorochemical or other hydrophobic finishings, to provide the requisite hydrophobicity. The non-woven layer, however, may equally be treated with coatings of liquid impervious materials such as hot-melt adhesives or coatings of silicone or other hydrophobic compounds such as rubbers and vegetable and mineral waxes or it may be physically treated using nano-particulates or plasma coating techniques, for example.

The non-woven layer can also be treated with agents to improve the tactile perceivable softness of the wearer facing portion 16 and the garment facing portion 17. The agents include but are not limited to vegetable, animal or synthetic oils, silicone oils and the like. The presence of these agents are known to impart a silky or flannel-like feel to the non-woven layer without rendering it greasy or oily to the tactile sense of the wearer. Additionally, surfactant material, including anionic, non-anionic, cationic and non-cationic surfactants, may be added to further enhance softness and surface smoothness.

Furthermore, the non-woven layer may be impregnated with a lotion to provide desirable therapeutic or protective coating lotion benefits. The lotion coating on the wearer facing portion 16 and the garment facing portion 17 is transferable to the skin of the wearer by normal contact and wearer motion and/or body heat. Generally, mineral oil in the form of a lotion is recognised as being effective in imparting a soothing, protective coating to the skin of the wearer. It is also possible to impregnate the non-woven layer with a solid oil phase of cream formulation or to incorporate into the non-woven layer an array of pressure- or thermal- or hydro-rupturable capsules containing for example, baby oil.

The faecal management device 10 of the present invention has been found to be particularly useful and beneficial when used in conjunction with a disposable diaper 50 - refer to Figure 3. The faecal management device 10 is first positioned in the perianal area of the wearer before the disposable diaper 50 is applied. In particular, the diaper 50 is positioned over the faecal management device 10 and fastened in a conventional manner around the body of the wearer. It has been found that, in addition, to providing excellent separation between urine and faecal material, the combined faecal management device 10 and diaper 50 system actually reduces skin irritation. In effect, the presence of the faecal management device 10 permits the formation of a separation layer between the skin of the wearer and the diaper 50, i.e., a part of the absorbent core 58 of the diaper 10. The diaper 50 can be of the conventional type (an embodiment of which is described below although not a limiting example by any means) or can be adapted to contain in an effective and comfortable manner the faecal management device 10 according to the teachings of the present invention.

As used herein, the term "disposable diapers" refers to articles which absorb and contain body exudates; and more specifically, refers to articles which are placed against or in proximity to the body of the wearer to absorb and contain the various exudates discharged from the body and which are intended to be discarded after a single use (i.e., they are not intended to be laundered or otherwise restored or reused) and, preferably, to be recycled, composted or otherwise disposed of in an environmentally compatible manner. As used herein, the term "diaper" refers to a garment generally worn by infants or incontinence sufferers that is drawn up between the legs and fastened about the waist of the wearer.

Figure 4 is a partially cut-away perspective view of a diaper 50 embodying the present invention prior to it being placed on the wearer over the faecal management device 10. As is visible from Figure 4, a preferred diaper 50 comprises a body portion 52 and a refastenable mechanical fastening device 54. A preferred body portion 52 comprises a liquid pervious topsheet 56, an absorbent core 58, a liquid impervious backsheet 60, and elastically contractible leg cuffs 62; each leg cuff 62 preferably comprising a side flap 64 and one or more elastic members 66. For simplicity purposes, only one elastic member 66 is shown in the side flap 64. While the topsheet 56, the absorbent core 58, the backsheet 60, the side flaps 64, and the elastic members 66 may be assembled in a variety of well-known configurations, a preferred disposable diaper configuration is shown and generally described in US 3,860,003. In this preferred diaper configuration, the backsheet 60 is joined to the topsheet 56; the absorbent core 58 is positioned between the topsheet 56 and the backsheet 60; the side flaps 64 extend outwardly from and along each side edge of the absorbent core 58; and the elastic member 66 is operatively associated with each side flap 64.

Figure 4 shows the body portion 52 in which the topsheet 56 and the backsheet 60 are coextensive and have length and width dimensions generally larger than those of the absorbent core 58. The topsheet 56 is superposed on the backsheet 60 thereby forming the periphery 68 of the body portion 52. The periphery 68 defines the outer perimeter or in other words the outer extent of the body portion 52. The periphery 68 comprises the longitudinal side edges 70 and lateral end edges 72. In the longitudinal direction, the diaper 50 has a first end region 78 and a second end region 80.

The body portion 52 has an inside surface 74 and an outside surface 76. In general, the outside surface 76 of the diaper 50 extends from one edge 72 to the other end edge 72 of the diaper 50 and from one longitudinal side edge 70 to the other longitudinal side edge 70 of the diaper 50. When a backsheet 60 is used, it typically forms the outside surface 76 of the body portion 52. The inside surface 74 is that surface of the diaper 50 opposite the outside surface 76 and in the embodiment shown is typically formed by the topsheet 56. In general, the inside surface 74 of the diaper 50 is that surface coextensive with the outside surface 76 and which is for the greater part in contact with the wearer when the diaper 50 is worn.

The diaper 50 has a first end region 78 and a second end region 80 extending from the lateral end edges 72 of the diaper periphery 68 towards the lateral centreline of the diaper 50. Both the first end region 78 and the second end region 80 extend a distance of about one-half the length of the diaper 50 such that the

end regions

78, 80 comprise each half of the diaper 50. Both the first end region 78 and the second end region 80 have panels 82. The panels 82 are those portions of the first end region 78 and the second end region 80 which overlap when the diaper 50 is fastened about the waist of the wearer. The extent to which the end regions 78 overlap and thus the extent to which the panels 82 are formed, will depend on the overall dimensions and shape of the diaper 50 and the size of the wearer.

The absorbent core 58 of the body portion 52 may be any absorbent means which is generally compressible, conformable, non-irritating to the skin of the wearer, and capable of absorbing and retaining liquids such as urine and other certain bodily discharges. The absorbent core 58 may be manufactured in a variety of sizes and shapes (for example, rectangular, hour-glass, "T"-shaped, asymmetric, etc.) and from a wide variety of liquid absorbent materials commonly used in disposable diapers and other absorbent articles such as comminuted wood pulp which is generally referred to as airfelt. Examples of other suitable absorbent materials include creped cellulose wadding, meltblown polymers including coform, crosslinked cellulosic fibers, tissue including tissue wraps, absorbent foams, absorbent sponges, superabsorbent polymers, absorbent gelling materials, or any equivalent materials or combinations of materials. The configuration and construction of the absorbent core 58 may also be varied (for example, the absorbent core 58 may have varying caliper zones, hydrophilic gradients, superabsorbent gradients, or lower average density and lower average basis weight acquisition zones; or may comprise one or more layers or structures). The total absorbent capacity of the absorbent core 58 should, however, be compatible with the design loading and the intended use of the pull-on diaper. Further, the size and absorbent capacity of the absorbent core 58 may be varied to accommodate wearers ranging from infants to adults.

The backsheet 60 is impervious to liquids (for example, urine) and is preferably manufactured from a thin plastic film, preferably a thermoplastic film, although other flexible liquid impervious materials may also be used. As used herein, the term "flexible" refers to materials which are compliant and which will readily conform to the general shape and contours of the human body. The backsheet 60 prevents the exudates absorbed and contained in the absorbent core 58 from soiling articles which are in contact with the diaper 50 such as undergarments and bedding. The backsheet 60 may thus comprise polymeric films such as thermoplastic films of polyethylene or polypropylene, or composite materials such as film-coated non-woven material. For economic, aesthetic and ecological reasons, the backsheet 60 has an average nominal caper, i.e., calculated caliper, of less than about 0.051 millimetres, more preferably a calculated caliper of from 0.020 millimetres to 0.036 millimetres. Preferably, the backsheet 60 is a flexible polyethylene film. As used herein, the term "polyethylene" film refers to films which are essentially made of polyethylene, however, it is understood that polyethylene film will contain a variety of additives to provide characteristics like opacity, strength requirements, colour, or any other desired characteristic that can be achieved through adding minor amounts of other substances than polyethylene into the films. The total amount of additives should be less than 45 percent, preferably less than 15 percent, by weight of film materials. Particularly, for opacity of the film, titanium dioxide is commonly used in a range of 2 to 6 percent, preferably 3.5 to 4.8 percent, by weight of the film. Exemplary films are manufactured by Tredegar Industries, Inc. of Terre Haute, Ind., USA or BP-Chemical PlasTec Rotbuchenstrasse 1, D-8000 München, Germany.

The backsheet 60 is preferably textured to provide a more clothlike appearance. Further, the backsheet 60 may also permit vapours to escape from the absorbent core 58 while still preventing exudates from passing through the backsheet 60 by, for example, being supplied with microapertures. The size of the backsheet 60 is dictated by the size of the absorbent core 58 and the exact diaper design selected.

The topsheet 56 of the body portion 52 of the present invention is compliant, soft feeling and non-irritating to the skin of the wearer. Further, the topsheet 56 is liquid pervious permitting liquids (for example, urine) to readily penetrate through its thickness. A suitable topsheet 56 may be manufactured from a wide range of materials, such as porous foams, reticulated foams, apertured films; or woven or non-woven webs of natural fibres (for example, wood or cotton fibres) or from a combination of natural and synthetic fibres. Preferably, it is made of a material that isolates the skin of the wearer from liquids retained in the absorbent core 58.

There are a number of manufacturing techniques which may be used to manufacture the topsheet 56. For example, the topsheet 56 may be a non-woven web of fibres. When the topsheet 56 comprises a non-woven web, the web may be spunbonded, carded, wet-laid, melt-blown, hydroentangled, hydroformed, combinations of the above, or the like. An exemplary topsheet 56 is carded and thermally bonded by means well-known to those skilled in the fabric art and comprise staple length polypropylene fibres having a denier of about 2.2 and has a basis weight from about 15 to about 30 grammes per square metre. As used herein, the term "staple length fibres" refer to those fibres having a length of at least 16 millimetres. A suitable topsheet 56 is manufactured by, for example, Veratec Inc., a division of International Paper Company, of Walpole, Mass., USA. A topsheet 56 particularly preferred for incontinence garments comprises a formed thermoplastic film.

GLOSSARY

10: Faecal management device
11: Bag
12: Flange
13: Lobes
15: Inner surface
16: Wearer facing portion
17: Garment facing portion
18: Periphery of bag
19: Section
50: Diaper
52: Body portion
54: Mechanical fastening device
56: Topsheet
58: Absorbent core
60: Backsheet
62: Leg cuffs
64: Side flaps
66: Elastic members
68: Periphery of body portion
70: Longitudinal side edges
72: Lateral end edges
74: Inside surface of body portion
76: Outside surface of body portion
78: First end region
80: Second end region
82: Panels

Claims

Faecal management device (10) comprising a bag (11), said bag (11) having an aperture and an anatomically-shaped flange (12) surrounding said aperture for adhesive attachment to perianal area of wearer, said anatomically-shaped flange (12) being attached to said bag (11), said bag (11) comprising at least two distinct portions: a wearer facing portion (16) and a garment facing portion (17), said wearer facing portion (16) and said garment facing portion (17) being secured at periphery (18) of said bag (11),
characterised in that
said wearer facing portion (16) has a surface area greater than said garment facing portion (17).
Faecal management device (10) according to claim 1 wherein said bag (11) has a substantially truncated cone shape.
Faecal management device (10) according to any of the preceding claims wherein said wearer facing portion (16) comprises more than one section (19).
Faecal management device (10) according to claim 1 wherein said wearer facing portion (16) is disposed adjacent buttocks of said wearer.
Faecal management device (10) according to any of the preceding claims wherein said wearer facing portion (16) and said garment facing portion (17) are provided with a non-woven layer.
Faecal management device (10) according to claim 5 wherein said inner surface (15) of said wearer facing portion (16) and said garment facing portion (17) comprises a plastic film.
Faecal management device (10) according to claim 5 wherein said inner surface (15) of said wearer facing portion (16) and said garment facing portion (17) comprises a second non-woven layer.
Use of a faecal management device (10) according to any of the preceding claims in combination with a disposable diaper (50).
Use of a faecal management device (10) according to claim 8 whereby said faecal management device (10) is first positioned in the perianal area of the wearer and then said disposable diaper (50) is positioned over said faecal management device (10) and fastened in a conventional manner around body of said wearer.
Use of a faecal management device (10) according to claims 8 and 9 wherein said faecal management device (10) provides a separation layer between skin of said wearer and said disposable diaper (50).